MedPath

Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda

Not Applicable
Conditions
Labor Long
Interventions
Behavioral: Support from a trained companion
Registration Number
NCT04771325
Lead Sponsor
Makerere University
Brief Summary

A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.

Detailed Description

The order of introduction of the intervention will be determined randomly. Control data will be obtained from the first health facility until the sample size for the control for that facility is achieved. Following collection of control data for the first facility, the intervention will be introduced to the same facility to a new group of participants. Simultaneously control data from the other facilities will be collected and this will be done until all the facilities are covered in a step wedge manner.

The intervention will consist of a session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
535
Inclusion Criteria
  1. Women with a singleton fetus and a supposed cephalic presentation.
  2. Women with a female friend or relative willing to stay with them through the process of labor and birth.
Read More
Exclusion Criteria
  • Women with a multiple pregnancy.
  • Women with a previous cesarean section
  • Women who are mentally incapacitated or deaf and dumb
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Arm 1Support from a trained companionWomen are normally escorted to the health facilities by one or more family members and or friends. Women usually labor in an open first stage room where more than one woman is admitted sometimes with curtains to separate the beds with one person allowed besides her to provide support. The support persons do not have designated roles to play during this process. Routine analgesia is not given neither is continuous fetal monitoring. Midwives,
Arm 2Support from a trained companionOne session of training on admission in labor. The training will focus on emotional and physical support; emotional support including being Present, demonstrating a caring and positive attitude, saying calming verbal expressions, using humor, praise, encouraging and acknowledging efforts during the process of pushing the baby. Physical support including supporting her to change position favoring upright positions, walking with her, giving her drinks and food, massage, reminding her to go and pass urine, helping her find a comfortable position for pushing, wipe her face with cool cloth and help her breast feed
Primary Outcome Measures
NameTimeMethod
Incidence of a Spontaneous Vaginal deliverylabour duration

delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section

Secondary Outcome Measures
NameTimeMethod
Length of labourlabour duration

From time of admission (4-6cm) to birth

Apgar scoreAt 1 and 5 minutes

Apgar score of baby at birth

coping and anxietylabour duration

Women's self-reported anxiety on admission and after birth will be measured using the 10 cm Visual Analogue Scales Coping with labour will be assessed using the Roberts coping with labour algorithm the midwife looks out for cues for coping and not coping

use of oxytocin to augment laborlabor duration

Use of oxytocin to augment labor

Maternal satisfaction questionnaireLabour duration

Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience

Trial Locations

Locations (1)

Mbale Regional Referral Hospital

🇺🇬

Mbale, Uganda

© Copyright 2025. All Rights Reserved by MedPath